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Description

Risk Management in Medical Devices: A Best Practice Course

Each year, regulators around the world receive several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Although these events may be caused by design flaws and use errors, it is the practice of risk management that is intended to catch these shortcomings before adverse incidents occur. The aim of this course is to equip attendees with the knowledge, skills and tools required to implement and maintain a best practice risk management process throughout the medical device lifecycle.

Course Contents

- General requirements for risk management

- Risk management process

- Management responsibilities

- Qualification of personnel

- Risk management plan

- Risk management file

The Medical Devices Directive and ISO14971

- Annexes ZA, ZB and ZC and what they mean in practice

Tools and Techniques:

- Hazard Analysis

- Fault Tree Analysis (FTA)

- Failure Mode and Effect Analysis (FMEA)

- Hazard and Operability Study (HAZOP)

- Risk Traceability Analysis

Software and Risk Management

- Software Hazard Analysis

- Software Fault Tree Analysis (FTA)

- Software Failure Mode and Effect Analysis (FMEA)

- Defensive Programming

The Safety Assurance Case

- Introduction to Safety Assurance Case (SAC)

- Elements of a SAC

- Establishing confidence in a SAC

- SACs in the product life cycle

- SAC formats and notations

- Creating a SAC

- Integrating SAC and risk management

- Software considerations in a SAC

- Reviewing a SAC

- Maintaining a SAC

- Tools for documenting a SAC

- Relationship with harmonized EU standards for medical devices

- Integrating multiple SACs

Relationship with other standards

- IEC62366

- IEC62304

Who should attend?

- R&D Managers

- Engineers

- Project Management

- Quality Assurance

- Regulatory Affairs

Outcomes

- A deep understanding of the risk management process

- In-depth knowledge of EN ISO 14971:2012 and its application

- The ability to apply state-of-the art tools and techniques

- An understanding of how to apply risk management to software systems

- Understand how to develop a Safety Assurance Case

- Have the skills required to plan, conduct, report and follow-up on risk management activities